The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study aims to evaluate how effective trazodone is in treating insomnia in adults aged 65 years and older. The main question it aims to answer is : \- Is trazodone more effective than a placebo in reducing the severity of insomnia symptoms in older adults? Participants will : * Take 25 to 50 mg of trazodone or a matching placebo before bed for 28 days. After a 2-week break, they will then take the other medication for another 28 days. * Visit the clinic three times for checkup and test * Complete a sleep diary and wear an actimeter during the night.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• Individuals aged 65 or older in an outpatient setting
• Insomnia according to the criteria of the ICSD-3R
Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Contact Information
Primary
Patrick Nguyen, B. Pharm, M.Sc.
patrick.nguyen.chum@ssss.gouv.qc.ca
514-890-8000
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 40
Treatments
Experimental: Crossover Trazodone then Placebo arm
Participants will receive 25 to 50 mg of trazodone once daily at bedtime for 28 days. After a 14-day washout period, participants will receive a placebo for another 28 days.
Experimental: Crossover Placebo then Trazodone arm
Participants will receive a placebo once daily at bedtime for 28 days. After a 14-day washout period, participants will receive 25 to 50 mg of trazodone for another 28 days.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)